Our top pharmaceutical client is looking to add a Validation Scientist to their growing team!

Responsibilities:

· Perform testing, analytical method validation and transfer activities of raw materials, in process (IP) and finished products (FP) samples to support Technical Services (TS) submission batches, according to SOPs and cGMP procedures

· Prepare method validation protocols/reports to meet project timelines

· Perform technical and specialized analytical tasks to support method validation, method transfer and technical investigations

· Supports extractables/leachables, nitrosamine impurity and elemental impurity studies

· Are required to adhere strictly to company policies and current industry standards.

Essential Job Functions:

• Sets up and operates instruments including (but not limited to) HPLC, LC-MS, GC, GC-MS, ICP-MS, UV/Vis, Automatic titration, IR, AA, TLC and dissolution apparatus to support sample testing.

• Performs testing, analytical method validation and transfer activities of raw materials, in process (IP) and finished products (FP) samples. Prepares standard and sample solutions as required by the test methods.

• Performs wet chemistry tests such as LOD, pH, and titration.

• Performs physical tests including thermal analysis, particle size, viscosity, and density measurements.

• Supports extractables/leachables, nitrosamine impurity and elemental impurity studies.

• Performs all necessary calculations associated with test analyses.

• Cleans, maintains and calibrates laboratory instruments to ensure compliance with cGLP and cGMP.

• Performs qualitative and quantitative analysis to support reference standard qualifications, method comparisons and transfers.

• Performs complex investigations and assists in identification of CAPAs/CPIs and prepares method validation/verification protocols, SOPs and reports.

QUALIFICATIONS

Bachelor’s Degree in Chemistry or related scientific field, with minimum 3 years experience OR Master’s Degree in Chemistry or related scientific field, with minimum 2 years experience in method validation in the pharmaceutical field.

• Knowledge and experience of spectroscopic and chromatographic techniques and concepts.
• Hands-on experience in setting up and operating any/all of following equipment: LC-MS, GC, GC-MS, ICP-MS.

· Hands-on experience in setting up and operating UV/IR, HPLC, TLC and dissolution apparatus.

• Working knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA requirements.
• Strong knowledge of qualitative and quantitative method validation parameters and their relevance in method performance.
• Strong technical writing skills, including SOPs, investigations, protocols and reports.
• Strong understanding of QA/QC systems, including change control systems.

INDNE1

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Relocation assistance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Monmouth Junction, NJ: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Laboratory experience: 1 year (Preferred)

Work Location: One location

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